Letter to the Editor: European Pharmacovigilance for Biosimilars is Robust and Provides Meaningful Information

Carlos Sattler, MD, is the head of clinical development and medical affairs at Sandoz, Inc. In this capacity, Sattler leads efforts in the United States to develop and implement Sandoz’s medical and scientific strategy, medical education and communication initiatives, and data-generation activities in support of biosimilars and other Sandoz products. Sattler specialized in pediatric medicine and is subspecialty trained in pediatric infectious diseases.
June 12, 2018
To the Editor,

I read with interest your article entitled “Panel Grapples With the Role of Biosimilars in Oncology” that reported on The Atlantic’s panel discussion of June 1, 2018, on the role that biosimilars will play in cancer care.

Although you accurately reported comments from Mr. Andrew Spiegel of the Global Colon Cancer Association, I am concerned that some of his statements will perpetuate misconceptions about biosimilars. Mr. Spiegel stated that the European experience with biosimilars was inadequate because the European health authorities did not require pharmacovigilance reporting with the same rigor as required in the United States, suggesting that we do not have convincing data supporting the post-approval safety profile of biosimilars marketed in Europe.

These assertions are far from the truth.

There are many European Union member countries with sizable populations that have advanced pharmacovigilance systems that are as excellent as any pharmacovigilance system in the world.

Ever since the approval of Omnitrope (somatropin) in Europe in 2006 as the world’s first biosimilar, EU health authorities have subjected all EU-approved biosimilars to the very same pharmacovigilance reporting standards, post-approval studies and periodic re-analyses of benefit-risk profile as any other newly approved biological drug.

Based on the extensive and well-executed pharmacovigilance reporting associated with 700 million patient-days of exposure to biosimilars in the European Union,1 the European Medicines Agency (EMA) concluded in 2017 that “The EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity or frequency of adverse effects between biosimilar medicines and their reference medicines.”2

Healthcare professionals and the public in the United States can be reassured: well-designed biosimilars approved to the standards of the FDA and EMA are as safe and effective for their intended use as their respective reference medicines.

1. Biosimilar Medicines Group, a Medicines for Europe sector group. Comment on the Food and Drug Administration Notice: Oncologic Drugs Advisory Committee meeting (Docket FDA-2017-N-2732). Regulations.gov. https://www.regulations.gov/document?D=FDA-2017-N-2732-0006. Published June 26, 2017. Accessed June 7, 2018.

2. European Medicines Agency. Biosimilars in the EU: Information guide for healthcare professionals. European Medicines Agency website. http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf. Published April 27, 2017. Accessed June 4, 2018.



Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars® is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747
Copyright © 2006-2020 Intellisphere, LLC. All Rights Reserved.